Evaluating the safety and effectiveness of tolvaptan in patients with heart failure and renal impairment: a systematic review and meta-analysis

Eur J Clin Pharmacol. 2025 Feb;81(2):203-216. doi: 10.1007/s00228-024-03778-3. Epub 2024 Nov 23.

Abstract

Purpose: Patients with heart failure and concomitant renal impairment are often prescribed loop diuretics, such as furosemide, as the primary treatment. The present meta-analysis is focused on analyzing the safety and efficacy of the implementation of tolvaptan as a novel approach in patients with renal impairment and heart failure.

Methods: Two reviewers conducted a screening of articles using online databases, including PubMed, Google Scholar, and Embase. Following a comprehensive literature search, seven articles that met all inclusion criteria (patients with heart failure and renal impairment) were selected for analysis. Subsequently, various primary and secondary outcomes were evaluated.

Results: The primary outcomes of our study included urine volume, worsening renal function, blood urea nitrogen (BUN) levels, and creatinine levels. Tolvaptan demonstrated superior efficacy in increasing urine output with a standardized mean difference of 2.18 (95% CI 0.62-3.75, p = 0.006) and resulted in a lower incidence of worsening renal function with odds ratio 0.41 (95% CI 0.22-0.77, p = 0.006). Additionally, there was no significant difference in the tolvaptan and conventional treatment groups in changing serum creatinine levels with a standardized mean difference of - 0.37 (95% CI - 0.86 to 0.12, p = 0.135), but tolvaptan tends to decrease blood urea nitrogen levels with a standardized mean difference - 0.18 (95% CI - 0.30 to - 0.06, p = 0.004) in comparison to conventional treatment group.

Conclusion: While tolvaptan administration was related to better renal outcomes, unresolved heterogeneities and various factors could have influenced our findings. Further research is needed to evaluate the role of tolvaptan in the treatment of this patient population.

Keywords: Heart failure; Loop diuretics; Meta-analysis; Placebo; Renal impairment; Tolvaptan.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Antidiuretic Hormone Receptor Antagonists* / adverse effects
  • Antidiuretic Hormone Receptor Antagonists* / therapeutic use
  • Benzazepines / adverse effects
  • Benzazepines / therapeutic use
  • Blood Urea Nitrogen
  • Creatinine / blood
  • Heart Failure* / blood
  • Heart Failure* / complications
  • Heart Failure* / drug therapy
  • Humans
  • Renal Insufficiency* / blood
  • Renal Insufficiency* / complications
  • Renal Insufficiency* / drug therapy
  • Tolvaptan* / adverse effects
  • Tolvaptan* / therapeutic use
  • Treatment Outcome

Substances

  • Antidiuretic Hormone Receptor Antagonists
  • Benzazepines
  • Creatinine
  • Tolvaptan